Purpose: To evaluate the efficacy and safety of rHuTPO/rHuIL-11 in the treatment for chemotherapy-induced thrombocytopenia in patients with NSCLC receiving gemcitabine and cisplatin or carboplatin chemotherapy.
Inclusion Criteria: 1. Patients aged 18 years -75 years, male or female; 2. histologically or cytologically confirmed non-small cell lung cancer; 3. consistent with the indication of chemotherapy 4. the decrease of platelets appeared in the screen chemotherapy period and the platelet count is less than 50 \* 109/ L; 5. the expected survival was more than 3 months; 6. patients must have the ability to understand and the willingness to sign a written informed consent; 7. to be able to follow the study and follow-up procedures Exclusion Criteria: 1. pregnant or lactating women; 2. patients who had severe allergic history on biological preparation; 3. the existing serious acute infection without control; 4. Patients receiving radiotherapy; 5. more than 3 metastatic tumor of bone were found in the screening period, and the platelet count did not restore to 100 \* 109/ L on the screening period on the seventeenth day of the screening period; 6. with a history of pulmonary embolism, myocardial infarction patients, thrombus history of thrombosis or activity in the past 3 months; 7. Sepsis, disseminated intravascular coagulation (DIC); hypersplenism or any other illness sickness that can exacerbate thrombocytopenia appeared in the previous cycles of chemotherapy; 8. tumor metastasis was found in the central nervous system;
Study Type
OBSERVATIONAL
Enrollment
120
Shanghai Chest Hospital
Shanghai, Shanghai Municipality, China
The mean minimal and maximal platelet count after rHuTPO or rHuIL-11.
Time frame: 28days
The time to achieve platelet count ≥75×109/L and ≥100×109/L after rHuTPO or rHuIL-11. The duration of platelet count <50×109/L after rHuTPO or rHuIL-11.
Time frame: 28days
The number of platelet transfusions after rHuTPO or rHuIL-11.
Time frame: 28days
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